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Home > "N" Clinical Trials Conditions > Novel Adjuvants for Peptide-Based Melanoma Vaccines  Novel Adjuvants for Peptide-Based Melanoma Vaccines
Novel Adjuvants for Peptide-Based Melanoma Vaccines
For Condition: Melanoma
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV melanoma.
Details: In the Phase I/II trial, patients with resected stages III and IV melanoma who have been rendered free of disease, but are at high risk of relapse, are treated with peptides/IFA at a dose of 0.5 mg each peptide plus CTLA-4 antibody given intravenously, 3 mg/kg, after each vaccination. In the Phase II randomized study, patients are treated with the melanoma peptide vaccine alone, with CTLA-4 antibody, or with CTLA-4 antibody combined with IL-12 at 30 ng/kg with alum. The peptides are tyrosinase 368-376 (370D); gp100 209-217 (210M); and MART-1 26-35 (27L) which are emulsified with IFA. The dosing schedule for both trials are at 1, 2, 3, 4, 5, and 6 months; then at 9 and 12 for a total of 8 vaccinations.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Diagnosis of stage III or IV cutaneous, mucosal, or ocular melanoma - Completely resected disease or disease-free - HLA-A2.1 positive - Tumor tissue available for immunohistochemical analysis and staining positive for at least 1 of the specified antigens - At least 1 month since prior therapy for cancer, including radiotherapy and adjuvant therapy - WBC count at least 3,000/mm3 - Granulocyte count at least 1,500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin at least 9.0 gm/dL - Creatinine no greater than 2.0 mg/dL - Bilirubin no greater than 2.0 mg/dL - SGOT/SGPT no greater than 2.5 times upper limit of normal - ECOG performance status 0-1 - Have failed alpha-interferons (patients with resected stage III disease) Exclusion criteria: - Prior treatment with tyrosinase: 368-376(370D), gp100:209-217(210M), and MART-1:26-35(27L) peptides - Steroid therapy or other immunosuppressive medication requirement - Major systemic infections (e.g., pneumonia or sepsis) - Coagulation or bleeding disorders - Major medical illnesses of the gastrointestinal, cardiovascular, or respiratory systems - Allergic reaction to Montanide ISA 51 (incomplete Freund's adjuvant) - History of uveitis or autoimmune inflammatory eye disease - Other active autoimmune disease - Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody - Pregnant or nursing
Total Enrollment: 72
Location and Contact Information:
Overall Study Official:
JeffreyWeber, Principal Investigator, University of Southern California/Norris Cancer Center
Universtiy of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center *Recruiting*
Los Angeles, California, 90089
United States
Recruiting Jeffrey Weber 323-865-3919
Additional Information:
Study ID Numbers: FD-R-1975-01; 10M-00-4;,FD-R-001975-01
Study Start Date: July 2001
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028431
Other Melanoma Studies:
1. IL-2 Gene Therapy for Metastatic Melanoma
2. A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion with Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients with Locally Advanced Extremity Melanoma
3. Study of Karenitecin (BNP1350) to treat Malignant Melanoma
4. gp100 and MDX-010 Vaccination for Stage IV Melanoma
5. A Phase II Study of Isolated Hepatic Perfusion (IHP) in Patients with Ocular Melanoma
Related Studies:
Other Melanoma Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Novel Adjuvants for Peptide-Based Melanoma Vaccines
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